TECNIS IOL ZCU150 (REF ZCU150U250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474657892), received between Jan 8, 2021 and Jul 3, 2024 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE NON-PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE, THE PATIENT'S DISTANCE VISION WAS BLURRY. THE PATIENT THOUGHT THE LENS WOULD IMPROVE DISTANCE VISION, BUT INSTEAD THE PATIENT IS ABLE TO SEE WELL CLOSE, UP TO TWO FEET, BUT DISTANCE IS BLURRY. THE PATIENT IS DISSATISFIED. AT THE POST-OPERATIVE VISIT ON (B)(6) 2024, THE PATIENT WAS TOLD THAT THE LENS WAS PLACED CORRECTLY AND IF UNHAPPY, LASIK, PRK OR A PIGGYBACK LENS COULD BE PERFORMED. THE PATIENT HAS GLAUCOMA. THE PATIENT IS SCHEDULED TO SEE THE DOCTOR AGAIN IN TWO WEEKS AND DOES NOT WANT THE LEFT EYE CATARACT SURGERY PERFORMED UNTIL THIS ISSUE CLEARS UP. THE PATIENT WILL BE SEEKING A SECOND OPINION. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE ISSUE WAS NOTICED TWO DAYS AFTER SURGERY; NEAR VISION WAS GOOD BUT ALL ELSE BLURRY. THIS IS STILL THE SITUATION AT ALMOST ONE MONTH, BUT THE DOCTOR ADVISED THAT SOME PEOPLE TAKE LONGER TO ADAPT. THE PATIENT CANNOT DRIVE SAFELY OR GROCERY SHOP UNLESS THE RIGHT EYE IS CLOSED, AS EVEN MID RANGE VISION IS NOT AS GOOD AS BEFORE. THE PATIENT CANNOT PLAY CROQUET. THE PATIENT IS UNABLE TO WORK ON THE COMPUTER UNLESS TEN INCHES FROM IT.

  Patient problems: Blurred Vision; Discomfort

  MAUDE report 19671770 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE DURING SECONDARY PROCEDURE. COMPLAINT DESCRIPTION, ANISOMETROPIA, DEBILITATING. ORIGINALLY, THE SURGEON TARGETED NEAR INTERMEDIATE VISION CORRECTION. PATIENT WAS NOT SATISFIED WITH THE REFRACTIVE OUTCOME WITH MEASURED OF RESIDUAL ASTIGMATISM. AFTER MANY VISITS, AND WAS REFERRED TO A CORNEAL SPECIALIST, A LENS EXCHANGE WAS REQUIRED. THE REPLACEMENT LENS IS A STANDARD MONOFOCAL LENS AND PATIENT IS HAPPY WITH THE SURGERY OUTCOME. PRE-OPERATIVE VISUAL ACUITY (VA) WAS 20/70 NEAR, AND POST-OPERATIVE VA IS 20/40 NEAR. AT EXPLANT THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURES WERE REQUIRED. THE EXPLANTED LENS WAS DISCARDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11143480 ↗